Breast Implants Black Box Warning – An Upgrade

Breast Implants labeling is getting an upgrade. Recently additional warnings have been added to help ensure the patient better understands the risks associated with this procedure and the long-term health risks.

There are over 400,000 women who get breast implants every year. This is an expanding area of health care and plastic surgery. This creates a problem of  an increased number of patient who feel that they weren’t informed adequately. The FDA is trying to better inform the public and create a better transparency with this procedure.

The warning label the FDA is trying to initiate will be included on the packaging for the breast implants. They also have recommended a patient checklist that goes through the risks including length of implant, and other medical risks. Overall, the information will explain the benefits and risks associated with the procedure and the implants themselves.

Advocates are concerned that it took this long to bring about the label changes. What exactly has changed?

There is a distinct opportunity to do more to protect women who are considering breast implants,” FDA officials said.

The truth is that patients are becoming victims to the variety of information available. Everyone has an opinion and not all that is being circulated is the truth. But on the opposite end, there are many patients who are unsatisfied with the results and felt they might make a different choice, had they known all the information. The overall goal is to clarify what can and can’t be expected and the risks associated.

Breast implants have been the number one cosmetic surgery for years. The biggest confusing point is the belief that the implants are meant for life. This is not necessarily true. Your body changes, but the implants stay the same. Typically, the implants are expected to last 10 – 15 years and an additional surgery or upgrade may be necessary at that point. Some patient may choose or may be required to have the breast implants removed at some later point. All patients going into this procedure must understand this important truth.

The second largest concern is what is termed as “Breast implant-related illness.” This illness is seen in less that 5% of those who get implants. But it is a real illness where the cause is not directly understood but there is a connection with the implants. Feelings of fatigue, fever, chills, Joint pains, weakness,  Breast pains, and other symptoms may be seen. Often, significant improvement is seen in the patient, once the breast implants are removed.

Overall the FDA has improved the process and changed the labeling of the risks and benefits. This is what they had to say:

We have heard from many women that they are not fully informed of the risks when considering breast implants. They’ve stated that they need more information to facilitate meaningful conversations with their doctors and to make appropriate decisions for themselves. Many stakeholders suggested that a boxed warning and patient decision checklist could provide this information,” the agency stated in a press release. “The agency appreciates this important feedback and, in today’s draft guidance, has proposed a number of recommendations designed to help inform conversations between patients and healthcare professionals when breast implants are being considered.”

This shouldn’t deter anyone from considering Breast Augmentation. The FDA is asking that additional research is done and make sure that you understand the process and risks. A better information patient is more likely to make a better decision.

Learn more about the FDA Implant Black Box Warning – here

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